Benzydamine HCl, cetylpyridinium chloride.
Difflam Gel is a clear, colourless, peppermint flavoured gel containing hydrochloride 1% (10 mg/g) and cetylpyridinium chloride 0.1% (1 mg/g).
Benzydamine is1-Benzyl-3-(3-dimethylaminopropoxy)-1H-indazole. Benzydamine hydrochloride is a white, odourless, crystalline powder with a bitter taste, soluble in water, ethanol, methanol and chloroform. It is sparingly soluble in ether and petroleum ether.
Cetylpyridinium chloride is 1-Hexadecylpyridinium chloride monohydrate. Cetylpyridinium chloride is a white unctuous powder with a slight characteristic odour, very soluble in alcohol and chloroform; very slightly soluble in ether.
Benzydamine hydrochloride and Cetylpyridinium chloride. Contains sodium saccharin.
Benzydamine is an anti-inflammatory analgesic agent structurally unrelated to the steroid group. Benzydamine differs chemically from other non-steroidal anti-inflammatory agents in that it is a base rather than an acid.
Animal models show that when administered systemically benzydamine is effective against pain and oedema due to inflammatory conditions. It also inhibits granuloma formation. At concentrations used for topical treatment, benzydamine possesses local anaesthetic action. Benzydamine does not cause erosion of the gastric mucosa when given orally to rats at doses up to 100 mg/kg.
The analgesic activity of benzydamine was more pronounced in models involving an experimental inflammation rather than in non-inflammatory pain. In common with the aspirin-like drugs, benzydamine possesses an anti-pyretic activity. Peripheral reflexes were transiently inhibited after intravenous administration to cats.
Pharmacodynamics: The mechanism of anti-inflammatory action is not related to stimulation of the pituitary-adrenal axis. Like other non-steroidal anti-inflammatory agents, benzydamine inhibits the biosynthesis of prostaglandins under certain conditions but its properties in this respect have not been fully elucidated. The stabilising effect on cellular membranes may also be involved in the mechanism of action.
Pharmacokinetics: Absorption: Benzydamine is well absorbed following oral administration. Following topical administration of benzydamine hydrochloride, benzydamine is well absorbed into the inflamed oral mucosa where it exerts anti-inflammatory and local anaesthetic action. Plasma benzydamine levels following use of benzydamine orally are low and paralled the amount actually ingested.
Excretion: Benzydamine and its metabolites are excreted largely in the urine. Metabolism is largely by oxidative pathways although dealkylation can also be shown. Benzydamine has been detected in blood and urine following use of oral solutions of benzydamine. Most of the absorbed dose was eliminated in the first 24 hours. Repeated administration for 7 days did not result in accumulation of benzydamine in plasma.
Temporarily relieves painful inflamed conditions of the mouth, including mouth and denture ulcers and sore gums.
Apply approximately 1 cm of gel with finger.
Gently massage into sore area.
Do not eat or drink for 15 min.
Apply every 2-3 hrs up to a maximum of 12 times/day.
With Impaired Renal Function: Since absorbed benzydamine and its metabolites are excreted in the urine the possibility of systemic effects should be considered in patients with renal impairment.
With Impaired Liver Function: Since absorbed benzydamine is highly metabolised in the liver the possibility of systemic effects should be considered in patients with severe hepatic impairment.
There are no known cases of overdosage with Difflam Mouth Gel. Adverse CNS effects have been reported following overdosage with high doses of benzydamine hydrochloride in solution form. There is no specific antidote for benzydamine and treatment should be symptomatic.
Difflam Mouth Gel is contraindicated in patients with known hypersensitivity to benzydamine or cetylpyridinium chloride or to any of the components of the vehicle.
If symptoms persist, see your doctor or dentist.
For use in patients with impaired renal or hepatic function see Dosage & Administration.
Use in Children: Because of the lack of sufficient clinical experience, Difflam Mouth Gel is not recommended in children under 6 years.
Studies in animals are inadequate or may be lacking, but available data show no evidence of an increased occurence of foetal damage. The safety of benzydamine hydrochloride has not been established in pregnant patients. Risk to benefit ratio should be established if Difflam Mouth Gel is to be used in these patients.
Difflam in topical oral preparations is generally well olerated and side effects are minor. The following adverse reactions have been reported after use of benzydamine hydrochloride in solution form:
Local Adverse Reactions: The most commonly reported reaction is oral numbness (2.6%). Occasional burning or stinging sensation may occur and has been reported in 1.4% of treated cases. Other local adverse effects were less common and included dryness or thirst (0.2%), tingling (0.2%), warm feeling in mouth and altered sense of taste (0.1%).
Systemic Adverse Reactions: These were very uncommon and never of a serious nature. They consisted mainly of nausea, vomiting, retching, gastro-intestinal disorders (0.4%), dizziness (0.1%), headache and drowsiness (0.1%).
Hypersensitivity reactions occur very rarely but may be associated with pruritis, rash, urticaria, photodermatitis and occasionally laryngospasm or bronchospasm.
There are no known drug interactions with benzydamine.
R02AX03 - benzydamine ; Belongs to the class of other throat preparations.
Difflam Mouth Gel
10 g x 1's
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